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EP-4565165-B1 - LUNG TREATMENT

EP4565165B1EP 4565165 B1EP4565165 B1EP 4565165B1EP-4565165-B1

Inventors

  • MAIBERG, Eduard

Dates

Publication Date
20260506
Application Date
20230804

Claims (12)

  1. A catheter system for treating a wound, comprising: a. at least one catheter (600) comprising proximal end and a distal end (602); said distal end comprising: i. one or more ultrasonic transmitters (604); ii. an inflatable balloon (606) covering said one or more ultrasonic transmitters; said inflatable balloon comprising a first electrode (612) located at a proximal location of said inflatable balloon and a second electrode (610) located at a distal location of said inflatable balloon; iii. a plurality of a first type of openings (616) located on a surface of said balloon; said location of said first type of openings being co-located to a location of said one or more ultrasonic transmitters on said catheter; iv. a plurality of a second type of openings (614) located on a surface of said balloon; said location of said second type of openings being co-located to a location of said first electrode.
  2. The catheter system according to claim 1, further comprising at least one liquid configured to inflate said inflatable balloon.
  3. The catheter system according to claim 2, wherein said at least one liquid comprises at least one drug.
  4. The catheter system according to claim 2, wherein said at least one liquid is saline.
  5. The catheter system according to any one of claims 1-4, further comprising one or more controls located at said proximal end of said catheter device and configured to control a movement of said distal end of said catheter device.
  6. The catheter system according to any one of claims 1-5, further comprising a video camera located at most distal end of said catheter device.
  7. The catheter system according to any one of claims 1-6, wherein said at least one catheter is configured to provide phonophoresis treatment.
  8. The catheter system according to any one of claims 1-6, wherein said at least one catheter is configured to provide iontophoresis treatment.
  9. The catheter system according to any one of claims 1-8, further comprising an external unit to which said at least one catheter is connected, said external unit comprising: a. a video unit comprising a navigation system, configured for manipulating said at least one catheter and provide visualization means from said video camera to a user; b. an electric field unit configured for generating an interference field; c. an ultrasonic unit configured to generate ultrasonic waves from about 0.5MHZ to about 3MHz, with a power up to 2 watts per cm 2 ; d. a calibration unit configured for specifying a attenuation coefficient in different locations and further configured for determining the optimal localization of said one or more ultrasonic transmitters; e. a pressure unit configured for maintaining and monitoring a pressure in said balloon; f. a phonophoresis pharmaceutical unit configured for monitoring and administering said at least one drug during phonophoresis treatment; g. a iontophoresis pharmaceutical unit configured for monitoring and administering said at least one drug during iontophoresis treatment.
  10. The catheter system according to claim 9, wherein said electric field unit is configured to provide current to a first catheter at a first frequency and to provide current to a second catheter at a second frequency.
  11. The catheter system according to claim 10, wherein said first frequency is of about 4000 Hz and said second frequency is from about 4100 Hz to about 4500 Hz.
  12. The catheter system according to claim 9, wherein said electric field unit is configured to provide electrical current which does not exceed 13 milliamps.

Description

RELATED APPLICATION/S This application claims the benefit of priority of U.S. Provisional Patent Application No. 63/395,380, filed on 5 August 2022. FIELD AND BACKGROUND OF THE INVENTION The present invention, in some embodiments thereof, relates to system and methods for local lung treatment and, more particularly, but not exclusively, to trans-bronchial therapeutic ultrasound - system and methods, for example for the treatment for ARDS, and thromboembolic complication of mediastinum (mediastinum condition). Local, non-invasive treatment of pulmonary tissue lesions, from inflammatory processes to ARDS, including oncological pathologies, are still very relevant and practically unresolved issues. Additionally, a potential advantage of performing therapeutic ultrasound is the ability to mechanically cleanse the wound, accelerate angiogenesis and angiokinesis, as well as accelerating tissue regeneration processes, which fulfils necessary criteria for the local treatment of a wide variety of tissues, from diabetic leg to reproductive organs. For many years, the lung has been considered off-limits for ultrasound. Features of the anatomical structure of the lungs, namely the presence of air in the pulmonary alveoli, which fully reflects ultrasonic waves, as well as an almost impassable ultrasound rib-muscular corset of the chest in which the lungs are located, make this organ practically impossible for the use of external therapeutic ultrasound. However, it has been recently shown that lung diagnostic ultrasound (LUS) may represent a useful tool for the evaluation of many pulmonary conditions, as mentioned in the review written by Laura Gargani, titled "Lung ultrasound: a new tool for the cardiologist". With ultrasound the clearest diagnostic vs. therapeutic definition would be that diagnostic ultrasound is used to assess medical conditions whereas therapeutic ultrasound is used to treat them. Additional background art for diagnostic ultrasound includes US patent N. US8961508 disclosing systems, assemblies, and methods to treat pulmonary diseases used to decrease nervous system input to distal regions of the bronchial tree within the lungs. Treatment systems damage nerve tissue to temporarily or permanently decrease nervous system input. The treatment systems are capable of heating nerve tissue, cooling the nerve tissue, delivering a flowable substance that cause trauma to the nerve tissue, puncturing the nerve tissue, tearing the nerve tissue, cutting the nerve tissue, applying pressure to the nerve tissue, applying ultrasound to the nerve tissue, applying ionizing radiation to the nerve tissue, disrupting cell membranes of nerve tissue with electrical energy, or delivering long acting nerve blocking chemicals to the nerve tissue. US patent N. US10307580B2 disclosing methods, devices and systems adapted for applying drugs or therapeutic agents to biological conduits, e.g., vascular lumens. More specifically, it discloses enhancing the uptake of drugs or therapeutic agents encapsulated in microbubbles in combination with ultrasound energy as well as applying drugs or therapeutic agents in a cyclic manner using a pulse generator that may be matched in frequency with a patient's blood pulsing. US patent application N. US20180193078A1 disclosing systems, methods and devices for the treatment of tissue. A system includes an elongate tube with a distal portion. A treatment element is positioned on the elongate tube distal portion, the treatment element constructed and arranged to treat target tissue. A scientific article by Liu et al, "Endobronchial high-intensity ultrasound for thermal therapy of pulmonary malignancies: simulations with patient-specific lung models", disclosing study for the feasibility of endobronchial ultrasound applicators for thermal ablation of lung tumors using acoustic and biothermal simulations. The study showed that simulations demonstrated the feasibility of endobronchial ultrasound applicators to deliver thermal coagulation of 2-3 cm diameter tumors adjacent to or accessible from major and deep lung airways. A scientific article by Bakamugesh et al, "Endobronchial ultrasound: A new innovation in bronchoscopy", disclosing the use of an EBUS mini-probe for analyzing the multilayered structure of the tracheobronchial wall and for performing biopsies of peripheral lesions. A scientific article by Donghi et al, "Pushing the boundaries: transesophageal endoscopic ultrasound-guided fine-needle aspiration for the diagnosis of intraparenchymal pulmonary micronodules", disclosing the use of Endobronchial ultrasonography (EBUS) videobronchoscope for transesophageal exploration (EUS-B-FNA). Thus, until now, for lung, exclusively diagnostic ultrasound has been used. Treatment of thromboembolic complications of mediastinum, especially pulmonary embolism, is still associated with high mortality. The most progressive technique for today is the introduction of a catheter with an ultrasonic sensor into the